A different liquid volume pre-charged needle sealing test cavity tool

Abstract

The utility model belongs to the field of medicine air tightness test, specifically disclose a kind of different liquid volume pre-filled needle sealing test cavity tool, including being sequentially located in same vertical level's pull rod cavity, upper cavity and lower cavity, pull rod is sequentially vertically through pull rod cavity, upper cavity and lower cavity, the upper cavity upper surface center is equipped with circular recess, the recess inside installation has composite seal ring, the utility model discloses by adjusting pull rod position, simultaneously to pull rod is fastened, sealed, effectively avoided the situation that medicine is contaminated due to the displacement of rubber plug during testing process;By using fixed screw to composite seal ring to exert pressure, compress composite seal ring, by the friction between composite seal ring and pull rod, fixed pull rod position and realize sealing;By accurate space design effectively reduces residual gap, makes test result more accurate;By fixed screw loose and tight free adjustment pull rod position to make structure simplify, easy operation.

Description

Technical Field

[0001] This utility model relates to the field of drug airtightness testing, specifically a tooling for a test chamber for the sealing performance of pre-filled needles with different liquid volumes. Background Technology

[0002] When assessing the airtightness of pharmaceutical products, especially sterile injectable products such as pre-filled syringes, different processes and pharmaceutical formulations present varying risks. Therefore, long-term airtightness testing is crucial. For example, sterile injectable products (small-volume pre-filled syringes) consist of a rubber stopper, a glass vial, and a push rod (the push rod may be omitted during testing). Whether this packaging system will change over a certain storage period necessitates periodic testing. In this case, non-destructive testing (NDT) becomes very important. The vacuum decay method can effectively assess the airtightness of pre-filled syringes and analyze the airtightness over a specific period. Below is a brief explanation of the vacuum decay method for testing pharmaceutical airtightness.

[0003] First, the medicine bottle is placed in a sealed chamber within the device, and a vacuum is applied. This vacuum causes gas to escape from the bottle through a leakage path. If the bottle contains liquid medicine, the liquid in the leakage path will vaporize when the vacuum level is lower than the liquid vapor pressure. Therefore, the increase in pressure within the sealed chamber is due to leakage from the pharmaceutical packaging. This pressure is detected by one or more sensors within the sealed chamber. In traditional detection chambers, the pressure inside the chamber is lower than the internal pressure of the medicine during the detection process, causing the rubber stopper to shift. This can lead to a risk of contamination of the medicine (because after the rubber stopper shifts, the previously exposed bottle wall will be in the same space as the liquid medicine). Different liquid volumes will result in different rubber stopper positions.

[0004] Therefore, in order to effectively fix the rubber stopper and achieve a seal inside the cavity, a test chamber fixture for the sealing performance of pre-filled needles with different liquid volumes is provided. Utility Model Content

[0005] The purpose of this invention is to provide a test chamber fixture for the sealing performance of pre-filled needles with different liquid volumes, so as to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, this utility model provides the following technical solution: a test chamber fixture for the sealing performance of pre-filled needles with different liquid volumes, wherein a tie rod cavity, an upper cavity and a lower cavity are located in the same vertical horizontal position, and a tie rod passes vertically through the tie rod cavity, the upper cavity and the lower cavity in sequence; The pull rod cavity and the upper cavity are connected by a fixing screw. The pull rod cavity has a pull rod cavity through hole at its center. The upper surface of the upper cavity has a circular groove at its center, and a composite sealing ring is installed inside the groove. The upper surface of the lower cavity has a trapezoidal sealing groove, and an O-ring is installed inside the trapezoidal sealing groove. The lower cavity has a lower chamber at its center. The test drug bottle is placed in the lower chamber. The pull rod passes through the pull rod cavity through hole, the composite sealing ring, and the upper cavity in sequence and is inserted into the lower chamber. The bottom of the pull rod contacts the rubber stopper sealing the test drug bottle. A test port is provided on one side of the lower cavity.

[0007] Preferably, a plurality of screw holes are evenly arranged on the tie rod cavity, and the fixing screw passes through the screw holes and is inserted into the corresponding threaded hole on the upper cavity.

[0008] Preferably, the composite sealing ring is composed of an annular plate and an annular sealing ring, with the annular sealing ring installed at the circular hole of the annular plate, and the pull rod passing through the circular hole on the inner side of the annular sealing ring.

[0009] Preferably, the trapezoidal sealing groove matches the shape of the O-ring, and the lower surface of the upper cavity and the O-ring seal the lower cavity.

[0010] Preferably, one side of the test port passes through the inner side of the lower cavity and is connected to the lower chamber.

[0011] Compared with the prior art, the beneficial effects of this utility model are as follows: By adjusting the position of the pull rod and simultaneously tightening and sealing it, this utility model effectively avoids the contamination of the medicine caused by the displacement of the rubber stopper during the test; by applying pressure to the composite sealing ring with a fixing screw, the composite sealing ring is compressed, and the friction between the composite sealing ring and the pull rod is used to fix the position of the pull rod and achieve a seal; the precise spatial design effectively reduces residual gaps, making the test results more accurate; and the ability to freely adjust the position of the pull rod by tightening and loosening the fixing screw simplifies the structure and makes operation simple. Attached Figure Description

[0012] Figure 1 This is a schematic diagram of the overall structure of this utility model; Figure 2 This is a cross-sectional view of the overall structure of this utility model.

[0013] In the diagram: 1. Pull rod cavity; 2. Upper cavity; 3. Lower cavity; 4. Pull rod; 5. Composite sealing ring; 6. O-ring; 7. Fixing screw; 8. Test medicine bottle; 9. Pull rod cavity through hole; 10. Screw hole; 11. Groove; 12. Threaded hole; 13. Trapezoidal sealing groove; 14. Test port; 15. Lower chamber. Detailed Implementation

[0014] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0015] In the description of this utility model, it should be noted that the terms "vertical", "up", "down", "horizontal", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0016] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0017] Please see Figure 1-2 This utility model provides a technical solution: a test chamber tooling for the sealing performance of pre-filled needles with different liquid volumes, wherein a pull rod cavity 1, an upper cavity 2 and a lower cavity 3 are located in the same vertical horizontal position, and a pull rod 4 passes vertically through the pull rod cavity 1, the upper cavity 2 and the lower cavity 3 in sequence; The pull rod cavity 1 and the upper cavity 2 are connected by a fixing screw 7. The pull rod cavity 1 has a pull rod cavity through hole 9 at its center. The upper surface of the upper cavity 2 has a circular groove 11 at its center. A composite sealing ring 5 is installed inside the groove 11. The upper surface of the lower cavity 3 has a trapezoidal sealing groove 13. An O-ring 6 is installed inside the trapezoidal sealing groove 13. The lower cavity 3 has a lower chamber 15 at its center. The test drug bottle 8 is placed in the lower chamber 15. The pull rod 4 passes through the pull rod cavity through hole 9, the composite sealing ring 5, and the upper cavity 2 in sequence and is inserted into the lower chamber 15. The bottom of the pull rod 4 contacts the rubber stopper sealing the test drug bottle 8. A test port 14 is provided on one side of the lower cavity 3.

[0018] After freely adjusting the position of the pull rod 4, tighten the fixing screw 7 so that it is in perfect contact with the rubber stopper of the test medicine bottle 8, thus avoiding the risk of the rubber stopper shifting and the medicine being contaminated during the test.

[0019] Furthermore, a plurality of screw holes 10 are evenly arranged on the pull rod cavity 1, and the fixing screw 7 passes through the screw holes 10 and is inserted into the corresponding threaded hole 12 on the upper cavity 2.

[0020] The position of the rubber stopper varies depending on the amount of liquid in the test medicine bottle 8. A fixing screw 7 is provided between the pull rod cavity 1 and the upper cavity 2 to facilitate the adjustment of the position of the pull rod 4.

[0021] Furthermore, the composite sealing ring 5 is composed of an annular plate and an annular sealing ring, with the annular sealing ring installed at the circular hole of the annular plate, and the pull rod 4 passing through the circular hole on the inner side of the annular sealing ring.

[0022] By applying tension to the composite sealing ring 5 between the tie rod cavity 1 and the upper cavity 2 using the fixing screw 7, the annular sealing ring inside the composite sealing ring 5 undergoes elastic deformation, gripping the tie rod 4 tightly. This fixes the position of the tie rod 4 and forms a reliable seal.

[0023] Furthermore, the trapezoidal sealing groove 13 matches the shape of the O-ring 6, and the lower surface of the upper cavity 2 and the O-ring 6 form a seal in the lower cavity 15. The cross-section of the trapezoidal sealing groove 13 is set to trapezoidal, which effectively reduces the possibility of the O-ring 6 falling off during the opening of the upper cavity 2.

[0024] Furthermore, one side of the test port 14 passes through the inside of the lower cavity 3 and is connected to the lower chamber 15.

[0025] Specifically: This invention effectively and completely fixes the pull rod 4 by placing a composite sealing ring 5 between the pull rod cavity 1 and the upper cavity 1; by using friction to fix and seal the pull rod 4 instead of other mechanical structures, the pull rod 4 presses against the medicine stopper to prevent it from shifting, greatly simplifying the structure used to fix the medicine.

[0026] By adjusting the position of the pull rod 4 and simultaneously tightening and sealing it, the contamination of the medicine due to the displacement of the rubber stopper during the test is effectively avoided. By applying pressure to the composite sealing ring 5 using the fixing screw 7, the composite sealing ring 5 is compressed, and the position of the pull rod 4 is fixed and sealed through the friction between the composite sealing ring 5 and the pull rod 4. The precise spatial design effectively reduces residual gaps, making the test results more accurate. The position of the pull rod 4 can be freely adjusted by loosening and tightening the fixing screw 7, simplifying the structure and making the operation simple.

[0027] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A fixture for testing the sealing performance of pre-filled needles with different liquid volumes, characterized in that: A tie rod (4) is located in the same vertical horizontal position in the tie rod cavity (1), upper cavity (2) and lower cavity (3), and passes vertically through the tie rod cavity (1), upper cavity (2) and lower cavity (3) in sequence. The pull rod cavity (1) and the upper cavity (2) are connected by a fixing screw (7). The pull rod cavity (1) has a pull rod cavity through hole (9) at its center. The upper cavity (2) has a circular groove (11) at its center. A composite sealing ring (5) is installed inside the groove (11). The lower cavity (3) has a trapezoidal sealing groove (13) at its upper surface. An O-ring (6) is installed inside the trapezoidal sealing groove (13). The lower cavity (3) has a lower chamber (15) at its center. The test drug bottle (8) is placed in the lower chamber (15). The pull rod (4) passes through the pull rod cavity through hole (9), the composite sealing ring (5), and the upper cavity (2) in sequence and is inserted into the lower chamber (15). The bottom of the pull rod (4) contacts the rubber stopper sealing the test drug bottle (8). A test port (14) is provided on one side of the lower cavity (3).

2. The fixture for testing the sealing performance of pre-filled needles with different liquid volumes according to claim 1, characterized in that: The tie rod cavity (1) has a number of screw holes (10) evenly arranged on it, and the fixing screw (7) passes through the screw hole (10) and is inserted into the corresponding threaded hole (12) on the upper cavity (2).

3. The fixture for testing the sealing performance of pre-filled needles with different liquid volumes according to claim 1, characterized in that: The composite sealing ring (5) is composed of an annular plate and an annular sealing ring. The annular sealing ring is installed at the circular hole of the annular plate, and the pull rod (4) passes through the circular hole inside the annular sealing ring.

4. The fixture for testing the sealing performance of pre-filled needles with different liquid volumes according to claim 1, characterized in that: The trapezoidal sealing groove (13) matches the shape of the O-ring (6), and the lower surface of the upper cavity (2) and the O-ring (6) seal the lower cavity (15).

5. The fixture for testing the sealing performance of pre-filled needles with different liquid volumes according to claim 1, characterized in that: The test port (14) is connected to the lower chamber (15) by passing through the inside of the lower cavity (3) on one side.

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